Overview of the Study Schedule and Tests1
If you decide to participate in the study, following are a few things to expect.
Prescreening, Screening, and Periodic Assessments
You will first be prescreened to determine whether your glioma has an IDH mutation and you are eligible to participate. If your tumor is confirmed to have an IDH mutation, you will then have screening assessments performed to see if you meet additional eligibility criteria.
If you meet all of the eligibility criteria and decide to take part in the study, you will have bi-weekly visits during the first 56 days while you are on study treatment. After that, the visits will be monthly, with a few additional visits toward the end of your participation. These visits will include a number of exams and evaluations including scans of your tumor. You will also be asked to self-report on a number of different aspects of your health.
If you are eligible for the INDIGO Study, you will be randomly assigned to receive either vorasidenib (40 mg, taken orally once a day) or a placebo (taken orally once a day). You’ll take your assigned study treatment every day during the study, fasting for 2 hours before and 1 hour after dosing, and will keep taking it until your disease progresses or you reach an unacceptable level of toxicity.
The study is double-blinded, which means neither you nor your doctor will know which option you are taking.
If after your disease progresses, it is determined that you were taking the placebo, you may be eligible to receive vorasidenib, provided certain eligibility criteria are met, and can continue to participate in the study.